Inc ClassII Novametrix Medical Systems

Company: Novametrix Medical Systems, Inc
Date of Enforcement Report: 11/7/01
Class: II

RECALL NUMBER, PRODUCT AND CODE:
Z-0216-2, Novametrix NICO Monitor, Model 7300 with software versions below 4.3

REASON:
Monitor may miscalculate Pulse Rate and Oxygen Saturation (SpO2) values.

MANUFACTURER/RECALLING FIRM:
Novametrix Medical Systems, Inc., Wallingford, CT

RECALLED BY:
Recalling firm by letter on 7/9/01

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide and Australia, Japan, Canada and Europe

QUANTITY:
699 units

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.